Pfizer recalls Chantix 1mg tablets due to potential N-nitroso-varenicline impurity exceeding FDA safety limits. Affected lots made in Ireland, expiring March 2023. Consumers should check NDC codes and contact Pfizer.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Pfizer is recalling Chantix 1mg tablets that may contain an impurity exceeding FDA safety limits. This could pose a health risk, so affected consumers should stop using the product and contact Pfizer for guidance.
The tablets may contain N-nitroso-varenicline impurities above the FDA's acceptable safety limit. This impurity could potentially cause health issues if consumed over time, though the exact risk is not specified in the recall.
People with a prescription for Chantix 1mg tablets from the recalled lots. Those who have taken the product without a prescription are not affected.
Check the NDC code 0069-0469-56 on the packaging. The product was made in Ireland and expires March 2023 (Lot EC9843 or EA6080).
Look for the NDC code 0069-0469-56 and expiration date of March 2023 on the packaging.
The recall states the product may contain an impurity above FDA safety limits, but the exact health risk is not specified.
Check the NDC code 0069-0469-56 and expiration date of March 2023 on the packaging.
The recall does not specify a remedy, so contact Pfizer directly for guidance.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0701-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0701-2021 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
